Spitalul Clinic de Recuperare Iași
Iași, Iaşi, 700686, Romania
NCT Number: NCT07825168
This prospective longitudinal study evaluated the feasibility, adherence, and clinical and functional effects of a 6-month home-based telerehabilitation program in patients with peripheral arterial disease of the lower limbs. The program consisted of walking-based physical activity monitored using a smartwatch and weekly telephone counselling. Patients were encouraged to progressively increase their daily physical activity, with assessments performed at baseline, 3 months, and 6 months.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Iași, Iaşi, 700686, Romania
This prospective, single-arm study evaluated the feasibility and implementation of a 6-month home-based telerehabilitation program in patients with peripheral arterial disease (PAD) of the lower limbs. The intervention consisted of an individually prescribed walking-based physical activity program performed at home, supported by wearable activity monitoring and weekly telephone counselling. Participants used a Xiaomi Smart Band 8 to monitor daily step counts and were encouraged to progressively increase their physical activity according to individualized weekly targets. During the weekly telephone contacts, the investigator reviewed the participant's activity during the preceding 7 days, assessed adherence and provided individualized encouragement and guidance regarding continuation and progression of the walking program.
Clinical, functional, laboratory, and health-related quality-of-life assessments were performed at baseline, 3 months, and 6 months. Functional evaluation included the 6-minute walk test, ankle-brachial index, and cardiopulmonary exercise testing. Laboratory assessments included selected cardiometabolic and inflammatory parameters. Disease-specific health-related quality of life was assessed using validated PAD-specific questionnaires.
The study was designed to evaluate the feasibility and adherence to a digitally supported home-based rehabilitation model and to explore longitudinal changes in physical activity, functional capacity, quality of life, and selected clinical and laboratory parameters during the 6-month intervention period. As the study used a single-arm design without a control group, longitudinal changes were considered exploratory and cannot be interpreted as causal effects of the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 6-month home-based walking program supported by smartwatch-based monitoring of daily step counts and weekly telephone counselling. During weekly telephone contacts, the investigator reviewed the participant's activity during the preceding 7 days, assessed adherence, and provided individualized guidance and encouragement to continue and progressively increase walking activity.
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which the participant achieved the average daily step target established for the following week.
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which average daily steps increased compared with the previous week.
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which the participant exceeded an average of 5,000 steps per day.
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which the participant exceeded an average of 10,000 steps per day.
Time frame: Throughout the 6-month intervention period
Median average daily step count during each 12-week period of the intervention.
Time frame: Baseline, 3 months, and 6 months
Distance (meters) walked until the onset of intermittent claudication symptoms during the 6-minute walk test.
Time frame: Baseline, 3 months, and 6 months
Total distance (meters) walked during the 6-minute walk test.
Time frame: Baseline, 3 months, and 6 months
Percentage of predicted 6-minute walk distance achieved during the test.
Time frame: Baseline, 3 months, and 6 months
Heart rate (beats/minute) measured during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
Maximum exercise workload (watts)achieved during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
Oxygen consumption (mL/kg/min) measured during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
Minute ventilation to carbon dioxide production ratio during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
Health-related quality of life assessed using the PADQOL questionnaire (points).
Time frame: Baseline, 3 months, and 6 months
Health-related quality of life assessed using the QOLPAD questionnaire (points).
Time frame: Baseline, 3 months, and 6 months
Health-related quality of life assessed using the VascuQoL-6 questionnaire (points).
Time frame: Baseline, 3 months, and 6 months
Systolic blood pressure (mmHg) measured during clinical assessment.
Time frame: Baseline, 3 months, and 6 months
Diastolic blood pressure (mmHg)measured during clinical assessment.
Time frame: Baseline, 3 months, and 6 months
Ankle-brachial index calculated as the ratio of ankle to brachial systolic blood pressure.
Time frame: Baseline, 3 months, and 6 months
Body mass index (kg/m²)calculated from body weight and height.
Time frame: Baseline, 3 months, and 6 months
Fasting blood glucose concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Glycated hemoglobin(%) measured during laboratory assessment.
Time frame: Baseline, 3 months, and 6 months
Serum total cholesterol concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Serum high-density lipoprotein cholesterol concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Serum low-density lipoprotein cholesterol concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Serum triglyceride concentration (mg/dL).
Grigore T. Popa University of Medicine and Pharmacy
Other
Results of a Study Based on a Telerehabilitation Program in Patients With Peripheral Arterial Disease of the Lower Limbs
Acronym: PAD_TR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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